Thursday, April 25, 2019

Nobody wants this much info from the FDA, but you NEED it



You can't get more TL;DR (too long; didn't read, for the non-millenials in the audience) than this document from the CBER and the FDA, but there is so much important stuff in here it can't be ignored.
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm636016.htm
Here are some of the highlights:



There is a lot to digest here, but it will be time well-spent.
Is there any area where you think the FDA is falling behind?  They clearly are trying to be proactive, but they are still going to move at the speed of bureaucracy.  What are they missing? 

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